» Cefmenoxime for Injection contains an amount of Cefmenoxime Hydrochloride equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefmenoxime (C16H17N9O5S3). It may contain Sodium Carbonate.

Packaging and storagePreserve in Containers for Sterile Solids as described under Injections 1.

B: The retention time of the cefmenoxime peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, both relative to the internal standard, as obtained in the Assay.

Pyrogen 151It meets the requirements, the test dose being 1.0 mL per kg of a solution of Cefmenoxime for Injection in sterile water for injection having a concentration of 60 mg of cefmenoxime per mL.

Sterility 71It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.

pH 791: between 6.4 and 7.9, in a solution containing the equivalent of 100 mg of cefmenoxime per mL.

Loss on drying 731Dry about 100 mg, accurately weighed, in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 1.5% of its weight.

Assay preparation 1 (where it is represented as being in a single-dose container)Constitute a container of Cefmenoxime for Injection in a volume of water, accurately measured, corresponding to the volume of diluent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and quantitatively dilute with water to obtain a solution containing the equivalent of about 1 mg of cefmenoxime (C16H17N9O5S3) per mL. Transfer 4.0 mL of this solution to a 50-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 80 µg of cefmenoxime per mL.

Assay preparation 2 (where the label states the quantity of cefmenoxime in a given volume of constituted solution)Constitute a container of Cefmenoxime for Injection in a volume of water, accurately measured, equivalent to the volume of diluent specified in the labeling. Quantitatively dilute an accurately measured volume of the constituted solution with water to obtain a solution containing about 1 mg of cefmenoxime (C16H17N9O5S3) per mL. Transfer 4.0 mL of this solution to a 50-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 80 µg of cefmenoxime per mL.

ProcedureProceed as directed for Procedure in the Assay under Cefmenoxime Hydrochloride. Calculate the quantity, in mg, of cefmenoxime (C16H17N9O5S3) withdrawn from the container or in the portion of constituted solution taken by the formula:

1.6(L / D)(WSPS / 1000)(RU / RS)

in which L is the labeled quantity, in mg, of cefmenoxime (C16H17N9O5S3) in the container or in the volume of constituted solution taken; D is the concentration, in µg of cefmenoxime per mL, of Assay preparation 1 or Assay preparation 2, based on the labeled quantity in the container or in the volume of constituted solution taken, respectively, and the extent of dilution; WS is the weight, in mg, of USP Cefmenoxime Hydrochloride RS taken to prepare the Standard preparation; PS is the designated cefmenoxime (C16H17N9O5S3) content, in µg per mg, of USP Cefmenoxime Hydrochloride RS; and RU and RS are the response ratios of the cefmenoxime peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.